BioCardia Reports Positive DSMB Review for CardiALLO Heart Failure Trial

BioCardia, Inc., a leader in the field of cellular and cell-derived therapies for cardiovascular and pulmonary conditions, announced a significant development in its CardiALLO-HF trial. The company's Independent Data Safety Monitoring Board (DSMB) has conducted a scheduled examination of safety data from the initial cohort, which included a 20 million cell dose. The result was favorable, with the DSMB recommending that the trial progress as initially planned. Notably, there were no major adverse cardiac events or immune reactions to the allogeneic cells among participants.

Peter Altman, the CEO of BioCardia, expressed satisfaction with the DSMB's recommendation. He emphasized that this milestone is crucial for progressing the off-the-shelf mesenchymal stromal/stem cell therapy. Altman added that the positive outcome of this review could play a pivotal role in discussions related to securing nondilutive funding and establishing partnerships for the company's MSC platform. Success in the ongoing trial may pave the way for pivotal trial designs in the U.S., conditional time-limited approvals with reimbursement in Japan, and advancements in therapy for both pediatric and adult congenital heart disease, which could be considered orphan indications.

The CardiALLO Heart Failure Trial is structured as a Phase I/II study. It features an initial Phase I open-label dose escalation cohort involving nine patients, followed by a Phase II randomized double-blind placebo-controlled cohort with 30 participants. The primary goal is to establish the safety and efficacy of this innovative treatment. During Phase I, three patients will receive escalating doses of 20 million, 100 million, and 200 million cells using the Helix minimally invasive delivery system. The proprietary CardiALLO human MSCs and their dedicated catheter delivery system are produced at BioCardia's manufacturing facility in Sunnyvale, California.

BioCardia's ongoing research builds on previous clinical findings from the TRIDENT trial, which demonstrated that higher doses of mesenchymal stem cells (MSC) could reduce myocardial scar tissue and improve left ventricular ejection fraction in patients with ischemic heart failure. Additionally, related research has shown that patients experiencing active inflammation can witness a sustained reduction in major cardiovascular events. The CardiALLO-HF trial aims to provide a higher dosage, potentially doubling the effective dosage seen in previous studies, and is uniquely targeting patients with active inflammation.

Headquartered in Sunnyvale, California, BioCardia is a global frontrunner in developing therapeutics for cardiovascular and pulmonary diseases. Their biotherapeutic platforms, CardiAMP and CardiALLO, are at the clinical stage with three product candidates in development. These therapies are supported by BioCardia's Helix biotherapeutic delivery system and Morph vascular navigation product platforms.

The company's strategic advancements and clinical trials highlight its commitment to pioneering new treatments that could significantly impact the management of cardiovascular diseases. The ongoing CardiALLO-HF trial, backed by the DSMB's positive review, represents a promising step in enhancing therapeutic options for heart failure patients and may lead to significant breakthroughs in the field.